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Completed

NCT Number: NCT04998110

Integrated Palliative Care With Nephrology Care

This study is a pilot randomized controlled trial testing the effectiveness of integrated ambulatory supportive care visits with standard nephrology outpatient visits for six months in patients with advanced CKD. The study team hypothesizes that patients in the integrated care arm will trend towards improved symptom burden, improved quality of life scores and more engagement in advance care planning.

Primary objectives: To test the impact of integrated ambulatory supportive care in nephrology care on symptom burden. Secondary: To test the impact of integrated ambulatory supportive care on quality of life and engagement in advance care planning and to demonstrate study feasibility.

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Key information

Conditions

CKD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYC Health + Hospitals / Bellevue

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • Documented diagnosis of Chronic Kidney Disease stage IV or V
  • Speaks Spanish or English fluently
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.

Exclusion criteria

  • Exposure to supportive/palliative care in the last six months either inpatient or outpatient.
  • Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation, for example not being able to cognitively understand the questions or to provide informed consent.
  • Pregnant women.
  • Not fluent in either English or Spanish
  • Any urgent supportive/palliative care needs identified on screening interview.

Treatment and study plan

Ambulatory Supportive Care

Other

Ambulatory supportive care visits monthly for six months - a monthly visit with an ambulatory palliative care provider educated in kidney disease

Primary outcomes

  1. Recruitment Rate

    Time frame: Month 12

    This will be reported as the percentage of participants who provide informed consent.

  2. Number of Participants who Maintain Participation in the Study (Retention)

    Time frame: Month 12

    Reported as percentage of participants who signed informed consent, who completed the study.

  3. Average number of clinical visits attended per participant (Retention)

    Time frame: Month 12

  4. Ability to Collect Planned Data

    Time frame: Month 12

    This will be reported as the percent of completed data surveys

Secondary outcomes

  1. Change in Kidney Disease Quality of Life (KDQOL-36) Score

    Time frame: Baseline, Month 6

    The KDQOL is a 36-item quality of life survey that includes five domains: Physical Component Summary (PCS), a Mental Component Summary (MCS), Burden of Kidney Disease Score, Symptoms and Problems of Kidney Disease Score, and Effect of Kidney Disease Score. All scores are on a scale of 0-100, with higher scores representing better quality of life.

  2. Engagement in Advance Care Planning

    Time frame: Baseline, Month 6

    Advance care planning will be measured by total number of advance care planning conversations held.

  3. Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score

    Time frame: Baseline, Month 6

    The scoring will include 11 questions on the degree of impact kidney-specific symptoms have had on patients over the past week, plus additional items on concerns beyond symptoms, such as information needs, practical issues, and family anxiety. This includes one question that has 15 sub-questions asking about specific physical symptoms. All scores are on a scale of 0-90, with lower scores representing less problems.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Pilot Randomized Controlled Trial of Integrated Palliative Care With Nephrology Care

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 10, 2021
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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